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June 16-20, 2024 | San Diego, CA
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    Maximize regulator confidence, Optimize safety compliance

    Enhance patient safety with our robust case processing, aggregate reporting, and signal management solutions. Increase regulator trust, and support market access through comprehensive, timely and accurate reporting while improving operational efficiency.

    Mitigate risks with REMS and Risk Management

    Unlock full market potential of your products by harnessing our expertise in developing Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMS). Our strategic advice empowers you to navigate regulatory complexities across therapeutic modalities.Ā 

    Real-timeĀ Medical Information supportĀ to yourĀ Patients and HCPs

    Provide best-in-class support to your patients and HCPs with our 24×7 integrated response center offering support in 100+ languages through customizable, end-to-end Medical Information services.

    Improve drug development andĀ approval processes acrossĀ product life cycle

    Strengthen your drug approval process and post-marketing surveillance across your portfolio by partnering with our team of experts who take complete ownership of Regulatory compliance, generating high-quality clinical and regulatory documents throughout the product life cycle.

    Inspection Readiness with Unsurpassed Quality Assurance

    Elevate your processes with our expertise in setting up a inspection-ready Quality Management System (QMS). Our meticulously developed risk-based programs ensures compliance and provides you with peace of mind at all times.

    Your Trusted Partner

    Manage complexity and compliance with Best-in-class subject matter experts - delivery teams comprising 100% HCPs including 100+ physicians
    Comprehensive support across the development life-cycle, from proof-of-concept to post-approval management
    Reinforce global expansion plans with safety capabilities in 100+ countries and Medical Information coverage in 50+ countries across 100+ languages
    Expansive coverage of your portfolio through our diverse therapeutic area and product expertise
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    Customized right fit solutions enabled through flexible delivery models
    Unparalleled quality, data privacy and information security with ISO 9001:2015, ISO 27701:2019, and ISO 27001:2022 certifications
    Technology-driven approach to comprehensive Compliance and Risk Minimization
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    Pharmacovigilance

    Medical Information

    Regulatory Affairs

    Medical Writing

    Testimonials

    • Medical Advisor, Medical Affairs
      I must commend the organizational skill, the professionalism, the clarity, the expertise on subject matter, execution excellence that APCER has exhibited in all my projects where I had collaboratedā€¦
      Medical Advisor, Medical Affairs
      A leading bio-pharma company
    • Global Clinical Leader
      My experience with APCER has been excellent. The team was very helpful, knowledgeable, responsive and professional with all the work that was needed.
      Global Clinical Leader
      A leading pharmaceutical company
    • Associate Submission Medical Writer
      APCER demonstrated extreme flexibility accommodating changes, and a number of last-minute changes were implemented quickly and correctly. I also appreciate the flexible communication during my workday, given the time zone differences between the APCER writers and myself.
      Associate Submission Medical Writer
      A leading bio-pharma company
    • Medical Director
      APCERā€™s speed, responsiveness and flexibility to meet our safety needs is something we have always valued. APCER has helped harmonize our global pharmacovigilance operations and made us compliant with ever changing regulations.
      Medical Director
      US-based specialty pharmaceutical company
    • QPPV and Pharmacovigilance Head
      The audit was carried out professionally and objectively. The scope of the audit was relevant and appropriate, and time efficient. The discussions during the audit were constructive and recommendations where helpful and appropriate. The team members involved in the audit had a positive experience and were made to feel at ease by the auditors.
      QPPV and Pharmacovigilance Head
    • Senior Director
      We are thankful to team APCER for bringing in strong practices & helping inspection readiness in our pharmacovigilance framework which led to successful FDA audits.
      Senior Director
      US-based pharmaceutical company
    • Head, Clinical Trial Transparency
      APCERā€™s invaluable support with Clinical trial disclosure deadlines helped us in timely submissions of periodic reports.
      Head, Clinical Trial Transparency
      Top 10 pharmaceutical company with operations in the EU and US
    • AVP, Pharmacovigilance
      We appreciate APCER for its efficiency in responding to matters that they get even at the eleventh hour. Working with APCER has made compliance a lot easier.
      AVP, Pharmacovigilance
      US-based pharmaceutical company
    • Senior Director
      We are thankful to team APCER for bringing in strong practices & helping inspection readiness in our pharmacovigilance framework which led to successful FDA audits.
      Senior Director
      US-based pharmaceutical company

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